Solone

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

SOLONE

Prednisolone (Pred-NISS-oh-lone)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SOLONE (prednisolone tablets). It does not contain all the available information
about SOLONE tablets. It does not replace talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking SOLONE against the benefits
he or she expects it will have.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What is SOLONE

The name of your medicine is SOLONE and is available in 5 mg and 25 mg tablet strengths.

The active ingredient is called prednisolone.

Prednisolone belongs to a group of medicines called corticosteroids.

Corticosteroids are used to help reduce inflammation in your body or suppress your immune system, when a disease may be due
to an auto-immune reaction (where your body fights against itself).

What SOLONE is used for

SOLONE is used to treat a number of medical conditions.

Your doctor will be able to help decide if SOLONE is suitable for your condition.

Ask your doctor if you have any questions about why SOLONE has been prescribed for you.

If you have any concerns, you should discuss this with your doctor.

This medicine is only available with a doctor's prescription.

Before you take SOLONE

When you must not take it

Do not take Solone if you are allergic to:

Prednisolone or other cortisone type medications, or any of the ingredients listed at the end of this leaflet including lactose.

Some of the symptoms of an allergic reaction to SOLONE may include urticaria and other skin rashes, difficulty breathing,
swelling of the face or throat or faintness.

Do not take SOLONE if you:

have a peptic ulcer

suffer from osteoporosis (brittle bones)

have severe disturbances in thoughts, feelings and behaviours (psychoneuroses)

have tuberculosis.

Do not take SOLONE if you are breastfeeding or plan to breast-feed.

Do not take SOLONE if you have any infections, including mumps, measles or chickenpox.

Do not use SOLONE after the expiry date (EXP.) printed on the pack.

If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected
effect.

Do not use SOLONE if the packaging is torn or shows any signs of tampering.

Do not give SOLONE to children, unless your doctor has prescribed it.

Before you start to take it

You must tell your doctor if:

1.You are allergic to any other medicines or any foods, dyes or preservatives

2.You have or have had any other medical conditions/health problems, including:

tuberculosis (TB)

a stomach ulcer

osteoporosis (brittle bone disease)

myasthenia gravis

congestive heart failure or have any other heart disease

diabetes

kidney failure

an underactive thyroid gland (hypothyroidism)

any infection (bacterial or fungal) including viral infections such as chicken pox or measles

3.Take Typhoid Vaccine.

Live or attenuated vaccines such as oral typhoid vaccine must not be taken with SOLONE.

4.You are pregnant or plan to become pregnant.

SOLONE like all medicines should not be used during pregnancy, unless your doctor tells you.

5.You are breastfeeding or plan to breastfeed.

SOLONE is expelled in breast milk and therefore should only be taken if your doctor tells you.

If you have not told your doctor about any of the above, tell them before you take any SOLONE.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines may interfere with SOLONE. These include:

medicines used to treat upset stomachs such as antacids

medicines used for diabetes including insulin

medicines used to treat tuberculosis such as rifampicin

medicines used to treat fungal infections such as ketoconazole

some medicines which have a high sodium content and also foods with a high sodium content - check with your pharmacist

some fluid reducing tablets, also called diuretics

barbiturates, medicine used to treat epilepsy

high doses of aspirin

potassium supplements.

growth hormones

digoxin or digitalis glycosides

course of vaccinations

The above medicines may either reduce the effectiveness of SOLONE and/or react with SOLONE resulting in untoward or sometimes
dangerous side effects.

Tell your doctor if you are taking SOLONE tablets before you undergo any laboratory test. SOLONE may interfere with laboratory
tests that check your thyroid.

Alcohol may interfere whilst you are taking SOLONE tablets.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while
taking SOLONE.

How to take SOLONE

How much to take

Your doctor will decide the right dose for you.

The dose you need depends on your medical condition, the treatment you are undergoing and your response to it.

How to take it

Swallow the medicine with water. If the dose is one-half tablet, there is a break-line on the tablet to help you divide it.

When to take it

Take SOLONE after meals at the time directed by your doctor.

How long to take it

Continue taking SOLONE as long as your doctor recommends it.

If you forget to take it

If your dosing schedule is one dose a day, take the missed dose as soon as possible, but not later than 4 hours before your
next dose. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and
Emergency at the nearest hospital, if you think that you or anyone else may have taken too much SOLONE. Do this even if there
are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent
medical attention.

Keep telephone numbers for these places handy.

If you take too much SOLONE you may have the following symptoms: weakness, convulsions, dizziness, headache, nausea, vomiting,
blurred vision, menstrual irregularities, and symptoms associated with electrolyte and fluid depletion and high blood pressure
(hypertension).

While you are using SOLONE

Things you must do

Use SOLONE exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking SOLONE.

Tell your doctor promptly if you become pregnant while you are taking SOLONE.

Tell your doctor if you feel SOLONE is not helping your condition.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking SOLONE.

Always discuss with your doctor any problems or difficulties during or after taking SOLONE.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough SOLONE to last weekends and holidays.

Things you must not do

Do not take any other medicines while you are taking SOLONE without first telling your doctor.

Do not drive or operate machinery until you know how SOLONE affects you.

SOLONE may cause dizziness in some people and therefore may affect alertness.

Make sure you know how you react to SOLONE before you drive a car, operate machinery, or do anything else that could be dangerous
if you are dizzy or have blurred vision.

Do not take SOLONE for a longer time than your doctor has prescribed.

Do not change your dose without first checking with your doctor.

Do not stop taking SOLONE or lower the dose, without first checking with your doctor.

Stopping this medicine suddenly on your own accord may cause some unwanted and dangerous effects, or your condition may reappear.
Your doctor will advise you when you can stop taking SOLONE completely.

Do not use this medicine to treat any other complaints unless your doctor says to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SOLONE.

SOLONE helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects
in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment
if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Short term use

When Solone is taken for short periods of time it is unlikely to cause any major problems.

Tell your doctor if you notice any of the following side effects and they worry you:

mood changes

nausea (feeling sick)

vomiting

increased appetite (which may result in weight gain)

stomach bloating or irritation

diarrhoea or constipation.

Long term use

When Solone is taken for long periods of time and in high doses the risk of side effects is greater.

Tell your doctor if you notice any of the following and they worry you:

General changes to the body:

bloating and rounding of the face (moon face)

headache

dizziness

high blood pressure

weight gain

redistribution of body fat

water retention leading to swollen legs and feet, high blood pressure or an irregular heart beat

cramps or weakness in the muscles of the arms and legs

slowed growth in children

irregular menstrual periods.

Changes to the skin:

acne

red or flushed face

red or purple streaks

easy bruising

skin thinning

increased sweating

poor wound healing

skin rashes.

Changes to the immune system:

an increased seriousness or frequency of infections.

Changes in behaviour:

excessive mood swings (such as changes in personality and loss of contact with reality)

anxiety or nervousness

depression

euphoria

restlessness

trouble sleeping.

Changes in eyes:

decreased or blurred vision

eyes sticking out too far

cataracts.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following
symptoms:

It is important to keep in mind that nontuberculous mycobacteria are environmental, and so unlike mycobacterial tuberculosis, generally this is not a person to person transmitted disease. The organisms are found universally in water and soil and so most people are exposed on a daily basis.

Aging is the continuing process of such stress exposures, and with advancing age (normal aging), we must carry lots of senescent cells within our bodies. Senescent cells also often provide some ‘bad influences’ to surrounding healthy cells; such as chronic inflammation and tumorigenesis

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